Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

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Detailed Description

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The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.

The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.

Conditions

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Neoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer Advanced Solid Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Selumetinib (AZD6244) 25 mg

monotherapy

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Tablet Oral bid

Selumetinib (AZD6244) 50 mg

monotherapy

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Tablet Oral bid

Selumetinib (AZD6244) 75 mg

monotherapy

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Tablet Oral bid

Selumetinib (AZD6244) 75 mg + Doce

Combination

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Tablet Oral bid

Selumetinib (AZD6244) 25 mg + Doce

combination

Group Type EXPERIMENTAL

AZD6244

Intervention Type DRUG

Tablet Oral bid

Interventions

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AZD6244

Tablet Oral bid

Intervention Type DRUG

Other Intervention Names

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Selumetinib (AZD6244)

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
* Patients who have overall good general conditions.
* Patients who have at least one lesion that can be accurately assessed by imaging.
* Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
* Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.

Exclusion Criteria

* Patients with brain metastases or spinal cord compression.
* Patients with significant abnormal ECG findings.
* Patients with evidence of severe or uncontrolled systemic disease.
* The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
* Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.

Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.

Patients with histologically or cytologically confirmed advanced solid malignancies.

Minimum Eligible Age

20 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No